BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDIHONEY GEL AND DRESSING

    MDR report key: 10307571 · Received July 21, 2020

    Report

    Report Number
    MW5095650
    Event Type
    Injury
    Date Received
    July 21, 2020
    Date of Event
    December 1, 2018
    Report Date
    July 18, 2020
    Manufacturer
    INTEGRA LIFE SCIENCES CORPORATION
    Product Code
    FRO
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS PRESCRIBED MEDIHONEY GEL (INTEGRA LIFE SCIENCES) TO USE AS A WOUND PROTECTANT. HE THEN DEVELOPED A SEVERE ALLERGIC CONTACT DERMATITIS DUE TO THE MEDIHONEY GEL. HE HAD A POSITIVE OPEN APPLICATION TEST WITH THE PRODUCT. NO REACTION TO PROPOLIS. HE IS ALLERGIC TO PROPYLENE GLYCOL, FRAGRANCES, AND TEA TREE OIL, NONE OF WHICH ARE LISTED AS INGREDIENTS ON MEDIHONEY GEL (LABEL SAYS 80% MANUKA HONEY, 20% "OTHER") FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766781 MEDIHONEY GEL AND DRESSING DRESSING, WOUND, DRUG FRO INTEGRA LIFE SCIENCES CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other